INBS News & Events

Intelligent Bio Solutions announced the launch of a validation study aimed at significantly reducing the analysis time of its Intelligent Fingerprinting Drug Screening System, IFDSS. The study aims to improve the already rapid time-to-result of INBS's drug screening technology, which collects samples in under a minute and provides results within ten minutes at the point of collection. Faster results will enable INBS to target the global roadside drug testing market with a first-in-class solution. "Speed matters in drug screening and is critical for roadside law enforcement," said Harry Simeonidis, President and CEO at INBS. "Moving from a ten-minute test to under three minutes changes the entire value equation for our customers. This validation study aims to confirm our encouraging preliminary findings and advance us toward our two-minute test goal."

Intelligent Bio Solutions announced the successful completion of penetration testing as part of its upcoming FDA 510(k) submission. The testing identified no major vulnerabilities, verified the robustness of the Company's existing security infrastructure, and strengthened its regulatory submission to the FDA. In conjunction with the penetration testing, INBS implemented additional security upgrades to its drug testing technology. These upgrades include enhanced encrypted identification tags to ensure test integrity and improved firmware safeguards that allow only authorized updates and protect against cyber threats. "Successful completion of penetration testing is another key milestone in our FDA 510(k) submission process. This independent assessment identified no major security vulnerabilities, confirming the effectiveness of our security approach," said Harry Simeonidis, President and CEO at INBS. "These new upgrades reflect our commitment to protecting donor data and implementing security measures that meet and exceed regulatory expectations, bolstering our upcoming 510(k) submission to the FDA."

Intelligent Bio Solutions announced the successful completion of its initial clinical cut-off study supporting the company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The clinical cut-off study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate device, and confirmed findings through liquid chromatography-tandem mass spectrometry analysis. INBS has now initiated the second phase of its clinical study program. This includes a multi-site Method Comparison and Usability Study. This study is designed to validate the system's accuracy, usability, and workplace performance when operated by intended end users at several clinical sites. The company expects to complete the method comparison and usability study by the end of June. In parallel with the method comparison and usability study, the company will be commencing an Interference study, which will test the device in the presence of potentially interfering substances found in real-world settings. Completion of the interference study is anticipated by the end of July.

Intelligent Bio Solutions announced the receipt and deployment of the first shipment of Intelligent Fingerprinting Drug Screening Readers manufactured under its new strategic manufacturing partnership with Syrma Johari MedTech .The shipment marks a significant step in scaling the Company's production capacity and validates the operational and financial benefits of the collaboration announced in December 2025. The readers are now being deployed across key customer verticals, including construction, transportation and logistics, and manufacturing, throughout the U.K. and Europe, supporting growing commercial demand and expanding the Company's installed base ahead of planned entry into the U.S. market, beyond the Forensic Use Only category, later this year.